Pinverin Application Trial to Reduce Bowel Uptake of FDG (Fluorodeoxyglucose)

NCT02173964 — Phase 4, Completed, 58 participants, Seoul National University Hospital

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Clinical Trial of Pinverin (Pinaverium Bromide) to Reduce Bowel Uptake of FDG in a Variety of Cancer Patients Who Undergo FDG PET/CT

Registry	NCT02173964
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, diagnostic
Enrollment	58 (Actual)
Sponsor	Seoul National University Hospital (Other)
Conditions	Cancer
Interventions	pinaverium bromide, water (Drug)
Dates	start 2014-07-01, primary completion 2015-11-01, completion 2015-11-01, first posted 2014-06-25, last updated 2016-04-15
Locations	1 site in South Korea

-Summary

1. Background

1. PET/CT (positron emission tomography/computed tomography) using FDG (fluorodeoxyglucose) is widely used for evaluation of cancer patients.
2. Bowel uptake of FDG is a serious problem that hampers the proper reading of PET/CT.
3. There is no widely-accepted method to reduce the bowel FDG uptake.
2. Purpose

1. To know whether pinverin (pinaverium bromide) application during PET/CT can reduce bowel uptake of FDG.
2. Pinverin is a calcium-channel blocker that ameliorates the bowel contraction.
3. Pinverin may be useful to reduce bowel FDG uptake by ameliorating the bowel contraction during PET/CT acquisition.
3. Method

1. Intervention versus control: administration of single tablet of pinverin (50mg) perorally versus simple water (\~100mL).
2. Timing of administration: At the time of FDG injection. PET/CT images will be acquired 1hr post FDG injection.
4. Primary outcome

1. SUV (standardized uptake value) difference between pinverin administered patient group versus control group.
2. SUV (standardized uptake value) is calculated as: (decay corrected radioactivity in mCi/mL) x (body weight in g) / (injected radioactivity in mCi)

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
pinaverium bromide	Experimental	Drug: pinaverium bromide	pinaverium bromide 50 mg tablet per oral administration one time
water	Placebo comparator	Drug: water	water \~100mL

pinaverium bromide (Drug), also known as pinverin: pinverin 50 mg per oral single dose versus simple water ingestion
water (Drug), also known as water~100mL: same amount of water for pinverin administration

+Outcome measures

Primary outcomes

SUV (standardized uptake value) [1 hour after FDG (the radiopharmaceutical for PET/CT) injection]: SUV is the quantitative parameter of FDG uptake during PET/CT and represents the degree of relative FDG uptake in a specific lesion. SUV is calculated as: (decay-corrected radioactivity in mCi/mL) x (body weight in g) / (injected radioactivity in mCi). The unit of SUV is g/mL.

+Eligibility

Sex: All, ages: 19 Years to 80 Years

Inclusion Criteria:

* Any cancer patients
* Candidate of positron emission tomography/computed tomography

Exclusion Criteria:

* Diabetes mellitus
* Inflammatory bowel disease
* Irritable bowel syndrome
* Peritoneal carcinomatosis
* Peritonitis
* Abdominal pain
* Diarrhea
* Medical test requiring bowel preparation within 1 month
* History of abdominal surgery
* Symptom or sign of colitis
* Pregnancy or lactation
* Hypersensitivity to pinaverium bromide
* Lactate intolerance
* Anit-depressant medication

+Locations (1)

Facility	City	Country	Status
Seoul National University Bundang Hospital	Seongnam-si, Gyeonggi-do	South Korea

+Investigators

Won Woo Lee, MD, PhD, Principal investigator, Seoul National University Bundang Hospital